BRPI0700681B1 - GASTRIC BAND, LOW PRESSURE, HIGH VOLUME - Google Patents

Abstract

A low pressure, high volume gastric band (410) includes a balloon (414) shaped and dimensioned to circumscribe the stomach at a predetermined location and a belt (412) extending about the balloon. The gastric band is precurved extend about the stomach and the balloon exhibits 360 degree coverage about the stomach.

Description

(54) Title: GASTRIC BAND, LOW PRESSURE, HIGH VOLUME (51) Int.CI .: A61B 17/12 (30) Unionist Priority: 01/03/2006 US 11 / 364,363 (73) Holder (s): JOHNSON & JOHNSON (72) Inventor (s): KRISTIN L. JAMBOR; JEFFREY P. WILEY

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Descriptive Report of the Invention Patent for GASTRIC RANGE, LOW PRESSURE, HIGH VOLUME.

CROSS REFERENCE TO RELATED APPLICATIONS [001] This application is a continuation in part of US Patent Application Serial No. 11 / 182,072, entitled LATCHING DEVICE FOR GASTRIC BAND, filed on July 15, 2005, which is currently pending and claims the United States Provisional Order Serial No. 60 / 699,369 benefit, entitled GASTRIC BAND, filed on July 15, 2005.

BACKGROUND OF THE INVENTION

1. FIELD OF THE INVENTION [002] The present invention relates to a gastric band and related accessories.

2. DESCRIPTION OF THE PREVIOUS TECHNIQUE [003] Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly pervasive in the United States, as well as in other countries, and the trend appears to be growing in a negative direction. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and lung failure with markedly reduced life expectancy. With this in mind, and as those skilled in the art will certainly appreciate it, the monetary and physical costs associated with morbid obesity are substantial. In fact, obesity costs are estimated to be in excess of $ 100 billion in the United States alone.

[004] A variety of surgical procedures have been developed to treat obesity. The most common procedure currently performed is Roux-en-Y gastric bypass (RYGB). This procedure is highly complex and is commonly used to treat people with morbid obesity. Other forms of bariatric surgery include Fobi sac, biliopancreatic diversion and gasPetition 870180006992, from 26/01/2018, p. 6/42

2/30 troplastic or stapling of the stomach. In addition, implantable devices are known, which limit the passage of food through the stomach and affect satiety.

[005] In view of the highly invasive nature of many of these procedures, efforts have been made to develop less traumatic and less invasive procedures. Gastric banding is one such method. Gastric banding is a type of gastric reduction surgery that tries to limit food intake by reducing the size of the stomach. In contrast to RYGB and other stomach reduction procedures, gastric banding does not require alteration of the anatomy of the digestive tract in the duodenum or jejunum.

[006] Since the early 1980s, gastric bands have provided an effective alternative to gastric bypass and other irreversible surgical weight loss treatments for the morbidly obese. Several alternative procedures are performed under the title of gastric banding. Some banding techniques employ a gastric ring, others use a band, some use stomach clamps and still others use a combination of rings, bands and clamps. Among the most commonly performed procedures are gastroplasty with vertical band (GBV), gastroplasty with silastic ring (SRG) and adjustable silastic gastric banding (AGB) [007] In general, the gastric band is wrapped around an upper portion of the stomach of the stomach forming a stoma that is smaller than the normal internal diameter of the stomach. This restricts the passage of food from an upper portion to a lower digestive portion of the stomach. When the stoma is of an appropriate size, the food held in the upper stomach provides a feeling of fullness that discourages overeating.

[008] More particularly, and in practice, the gastric band is inserted behind the stomach and the ends of the gastric band are attachedPetition 870180006992, of 26/01/2018, p. 7/42

3/30 to secure the device around the stomach. However, it is often difficult to maneuver the ends of the gastric band for proper locking. As such, mechanisms to optimize the application of gastric bands around the stomach are needed. The present invention provides such a mechanism in the form of an extension device for use in conjunction with currently available gastric bands, which is removable after the gastric band is properly installed. The present invention also provides improved gastric band construction that is easy to apply around a stomach and enhanced functionality once applied. SUMMARY OF THE INVENTION [009] It is therefore an objective of the present invention to provide a low-pressure, high-volume gastric band that includes a balloon shaped and sized to circumscribe the stomach at a predetermined location and a belt that extends around the balloon . The gastric band is pre-curved, extends around the stomach and the balloon shows 360 degree coverage around the stomach. [0010] It is also an objective of the present invention to provide a method for applying a low pressure, high volume gastric band, composed of a balloon shaped and sized to circumscribe the stomach in a predetermined location, in which the balloon has a maximum volume filling.

[0011] Other objectives and advantages of the present invention will become apparent from the following detailed description, when viewed in conjunction with the accompanying drawings, which present certain embodiments of the invention

BRIEF DESCRIPTION OF THE DRAWINGS [0012] Figure 1 is a perspective view of the suture flap extender attached to a gastric band.

[0013] Figure 2 is a perspective view of the removable suture flap extender.

[0014] Figure 3 is a perspective view of the prePetition gastric band 870180006992, from 26/01/2018, p. 8/42

4/30 s around the stomach.

[0015] Figures 4, 5 and 5a are various views in perspective of a gastric band according to the present invention.

[0016] Figures 6, 7 and 8 show the various steps in fixing the gastric band using the present suture flap extensor.

[0017] Figure 9 is a perspective view of a suture flap extender according to an additional embodiment.

[0018] Figure 10 is a perspective view of a suture flap extender according to an alternative embodiment.

[0019] Figures 11, 12, 13 and 14 show, respectively, a perspective view of a balloon, a perspective view of a belt, a cross sectional view of a gastric band and a perspective view of the gastric band accordingly with another embodiment of the present invention.

[0020] Figures 15 and 16 show, respectively, a perspective view of a gastric band and a cross-sectional view of the gastric band according to an alternative embodiment of the present invention.

[0021] Figure 17 is a cross-sectional view of a gastric band according to another embodiment of the present invention.

[0022] Figures 18, 19, 20 and 21 show, respectively, a perspective view of a belt, a perspective view of a balloon, a cross-sectional view of a gastric band and a perspective view of the gastric band accordingly with yet another embodiment of the present invention.

[0023] Figures 22 to 31 show various modalities of a balloon-like gastric band with different supply tube locations.

[0024] Figures 32 to 43 show various types of suture flap extenders with different fixation structures.

DESCRIPTION OF THE PREFERRED EMBODIMENTS [0025] The detailed embodiments of the present invention are

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5/30 described here. It should be understood, however, that the described embodiments are merely exemplary of the invention, which can be considered in several ways. Therefore, the details described herein should not be construed as limiting, but merely as the basis for claims and for teaching those skilled in the art how to carry out and / or use the invention.

[0026] With respect to figures 1 and 2, a removable suture flap extender 100 for use in conjunction with a gastric band 10 is shown. The extensor 100 is designed to optimize the use of gastric bands 10 and assist in the use of the gastric band locking mechanism 20. In particular, the extender 100 provides a mechanism to assist the passage of the first locking member 22 of the locking mechanism 20 through the second locking member 26 of the locking mechanism 20 by means of screwing or pressing the first locking member 22 through the second locking member 26 or by inserting a fastener through the second locking member 26, squeezing the tip of the extender 112, and pressing it back through the second locking member 26 to lock.

[0027] To attach the extensor 100 to the gastric band, the securing strip 1098 is then glued to the rest of the extensor 100 within a coupling notch 110. according to an alternative embodiment, and with reference to Figure 10, the extensor 200 can be provided with a pocket 311 positioned at the end of the coupling notch 310 into which the fastening strip 308 can be glued. [0028] The extensor 100 is easily removed or cut from the gastric band 10 once the gastric band 10 is properly positioned and fastened around the stomach, thereby minimizing the risk of sharp band edges if the band itself is cut . To remove the extender 100, the securing strip 108 is cut between the opening 38 at the tip 36 of the gastric band 20 and the coupling notch 110, containing the securing strip 108 attached. This allows 870180006992, of 26/01/2018, p. 10/42

6/30 have the extensor 100 removed in one piece, leaving gastric band 100 completely intact, without any sharp band edges.

[0029] The extender 100 can still be provided with a recess 109 (see figure 2) of the extender 100 to insert scissors between the tip 36 of the gastric band 20 and the strip to hold 108 to better facilitate the cutting of the extender 100. The extender 100 is completely removed from the body after it has been cut from the gastric band 10. Extender 100 also allows the creation of a temporary lock, allowing adjustment around the stomach before the final locking of the locking mechanism 20. Although a preferred modality has the extensor cut for removal in a gastric band body part, an alternative modality will entail leaving the extensor in place in the gastric band using the temporary lock (that is, the retaining element 114, 214, which is described in more detail below ) as an additional permanent locking position for use with varying stomach sizes.

[0030] In practice, and with reference to figure 3, the present suture flap extender 100 is attached to the first end 14 of the gastric band 10 adjacent the first locking element 22 to form a single functional band-extender unit. Then, the gastric band 10, with the extensor 100 attached to it, is inserted behind the stomach. The first locking element 22 of the locking mechanism 20, as well as the extender 100, are then pushed or pulled through the second locking element 26 of the locking mechanism 20. The addition of the present suture flap extender 100 provides a longest region for grasping and manipulating the first locking element 22 as it passes around the stomach and through the second locking element 26.

[0031] According to a preferred modality, and as will be discussed in more detail below, the suture flap extender

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7/30

100 is an elongated, elastomeric component that attaches to the first end 14 of the gastric band 10 to assist in matching the locking of the first locking element 22 with the second locking element 26. The extender 100 is preferably attached to a flap 24 at the first end 14 of the gastric band 10 to hold the extensor 100 in place. The extender 100 is removable with a cut through the strip to secure 108 to the extender 100 and incorporates an indentation or an open indentation, for example, a cup-like feature 106 for coupling the first end 14 of the gastric band 10 and the extender 100 together so that they move as an integral unit.

[0032] More specifically, and as will be better appreciated on the basis of the following exposure, the flap 24 of the gastric band 10 is positioned inside the recess 106 of the extensor 100 and is securely and fixedly coupled to it using a strap to secure 108. In addition furthermore, according to the preferred embodiment, the second end of the extender may include a suture loop 105 for compatibility with a Goldfinger 150-like device. As those skilled in the art will certainly appreciate, the Goldfinger 150-like device assists in the passage of the band gastric 20 through the retrogastric tunnel. Alternatively, for surgeons who use other devices to pass the gastric band 20 through the retrogastric tunnel, the gripping section, or flat tip, 112 of the extensor 100 is compatible with these band-passing devices equally. In general, a Goldfinger instrument is an articulated band-passing device used to perform blind dissection behind the stomach, before the gastric band is passed. It is articulated and fed behind the stomach. At the tip of Goldfinger's instrument there is a notch that a suture loop can reach. Once the suture is achieved, a Goldfinger instrument is pulled out of the retrogastric tunnel and the suture loop pulls the band with it. Alternatively, to facilitate the use with these other pass devicesPetition 870180006992, of 26/01/2018, pg. 12/42

8/30 band length, a length of the extender can be round (like tubing) behind the flat end so that the extender is easier to orientate.

[0033] The removable extensor 100 is intended for use with a variety of gastric bands. As an example, the extensor is intended for use with gastric bands as described in US Patent Application Serial No. 11 / 182,072, commonly owned, filed on July 15, 2005, entitled LATCHING DEVICE FOR GASTRIC BAND, which is here incorporated by reference.

[0034] In general, and with reference to figures 4, 5 and 5A, the gastric band 10 includes a band body 12, having a first end 14 and a second opposite end 16. The band body 12 and the locking mechanism 20 are preferably made of silicone. Although, and as will be discussed in more detail below, the gastric band is a balloon-type gastric band, the present locking mechanism can be used in conjunction with a variety of band structure, without departing from the spirit of the present invention.

[0035] As mentioned briefly above, gastric band 10 is shaped and sized to circumscribe the stomach at a predetermined location, reducing the size of the stomach. The gastric band 10 employs a flexible locking mechanism 20 capable of locking and unlocking without destroying the locking mechanism 20 or significantly reducing retention capacities after further locking. The first and second ends 14, 16, respectively, act as male and female elements, depending on the direction of movement and the intention to lock or unlock the locking mechanism 20 of the present gastric band 10.

[0036] The first end 14 includes a housing element, or first locking element 22, generally composed of a hollow, half-moon shaped housing with a flap 24 for gripping and pulling through a collar element, or second traPetition element 870180006992, of 26/01/2018, p. 13/42

9/30 flange 26, consisting of a semicircular opening 30 at the second end 16. Half moon housing of the first locking element 22 bends as it is pulled or pushed through the collar element 26 by claw clamps . The collar element 26 includes a tongue 22 so that the housing element 22 slides through the semicircular opening 30 and under the tongue 28 during locking. Once the housing element 22 passes the tongue 28, the roles change. The first end 14 functions as a female component, when the housing element 22 resiliently returns to its original shape and is allowed to slide back to the second end 16 (now a male component) and through the tongue 28. As such, the housing element 22 functions as a male component and a female component during operation of the locking mechanism 20 and the collar element 26 functions as a male component and a female component, during operation of the locking mechanism 20; that is, the housing element 22 functions as a male component during insertion through the collar element 26 and a female component thereafter, when the tongue 28 is seated thereon. Unlocking is achieved by using claw clamps to pull the first end 14 forward, away from the second end 16, removing the tongue from the housing element 22. The M shape of the housing element 22 allows it to fold and move under the tongue 28 and through the collar element 26.

[0037] More particularly, the casing element 22 at the first end 14 of the gastric band 10 is, in general, a half-moon casing with a wide, open end, 32 tapering towards a narrow end 34 adjacent the tip 36 from the first end 14. The housing element 22 is substantially hollow and is formed of a material, for example, silicone, which allows for its compression and expansion.

[0038] Referring to figure 5a, the housing element 22

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10/30 is formed by a substantially M-shaped outer surface 23a, when viewed from its wide end 32. That is, the outer surface of the housing element 22 has a substantially M-shaped profile, while the inner surface of the element housing 22 adjacent the wide end 32 has a substantially smooth semicircular profile. It has been found that the unique M-shaped profile improves flexibility and control, while the housing element 22 is passed from the collar element 26. Furthermore, the inclusion of the M shape on the wide end 32 of the housing element 22 allows ease of release since it will be easier and more controllable for someone to compress the housing element 22.

[0039] The housing element 22 is slid through the collar element 26, as discussed above. Then, the center 54 of the wide M-shaped end 32 returns to its original shape and fits over the tongue 28. When the gastric band 10 is unlocked, the wrapping element 22 is pulled forward, away from the wrapping element. collar 26 and the M-shaped housing element 22 allows it to move under the tongue 28 and through the collar element 26. The precast shape of the housing element 22 not only acts as a guide feature for the tongue 28 to slide under the housing element 22 during unlocking, but it also allows the housing element 22 to slide back more easily through the opening 30 of the collar element 26.

[0040] An opening 38 is formed within the flap 24, adjacent to the tip 36 of the first end 14 and the narrow end 34 of the casing element 22. The opening 38 is shaped and sized to receive a commonly used suture or clamp. in the installation of gastric bands. In addition, the flap 24 is formed with protrusions 39 that assist in gripping the flap 24 during locking and unlocking.

[0041] Also at the first end 14, but on the opposite side of the housing element 22 from the opening 38 and adjacent to the end

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11/30 wide 32 of the housing element 22 is a rearwardly extending grip element 51. The grip element 51 is shaped and sized to allow double directional access for locking and unlocking 20. More particularly, the grip element 51 includes protrusions along their top and bottom surfaces 53, 55. These protrusions facilitate their gripping along a first directional orientation. The gripping element 51 is further formed in an hourglass shape, having a reinforced central section 57. The reinforced central section 57 allows gripping in a second dimensional orientation.

[0042] Secure fixing of the housing element 22 with the collar element 26 is achieved by ensuring that after the housing element 22 compresses while passing through the collar element 26, the housing element 22 returns to its original shape and the wide end 32 of the housing element 22 rests with the first edge 46 of the collar element 26.

[0043] The locking is further accentuated by providing the collar element 26 with a tongue 28 that extends from the collar element 26 away from the tip 50 of the second end 16. The tongue 28 is shaped and dimensioned to fit inside the end wide 32 of the housing element 22, after the housing element 22 has passed through the collar element 26 and the gastric band 10 is tensioned as the first and second ends 14, 16 are pulled towards each other with the housing element housing 22 forcing it to move back through the collar element 26 towards an unlocked position. With this in mind, the tongue 28 can be oriented downwards so that it slides with housing element 22 conveniently and securely. The tongue 28 can be distinctly colored to provide an indication as to whether the locking mechanism 20 is properly locked.

[0044] The grip of the second end 16 is additionally optimized by providing a gripping elementPetition 870180006992, from 26/01/2018, pg. 16/42

12/30 forward facing 58, this is a gripping element facing the end 50 of the second end 16. The forward facing gripping element 58 is shaped and sized to allow double directional access for locking and unlocking the locking mechanism 20. More particularly, the gripping element 58 includes protrusions 59 along the top and bottom surfaces 62, 64 thereof. These protrusions 59 facilitate their grip during a first directional orientation. The gripping element 58 is further formed in an hourglass shape, having a reinforced central section 60. The reinforced central section 60 allows gripping in a second directional orientation.

[0045] Grip element 58 is shaped and dimensioned to receive and center the housing element 22 as it passes through the collar element 26. Grip element 58 also assists in compressing the housing element 22 as it it passes through the collar element 26.

[0046] According to one embodiment of the present invention, the gastric band is a balloon-type gastric band, as shown in figures 11 to 16. With this in mind, gastric band 410 is, in general, composed of a reinforcement 412 to which an elongated balloon 414 is attached. Belt 412 includes a first end 416 and a second end 418 to which the first and second locking elements 422, 426 are attached, respectively. The belt 412 further includes an inner surface 428 and an outer surface 430. The outer surface 430 is substantially smooth and forms a substantial portion of the outer surface 431 of the gastric band 410, when attached around a patient's stomach. The inner surface 428 of the belt 412 is shaped and dimensioned for attachment to the outer surface 438 of the balloon 414.

[0047] With respect to balloon 414, it also includes a first end 432, a second end 434, an inspection surface 870180006992, of 26/01/2018, p. 17/42

13/30 tender 436 and an outer surface 438. The inner surface 436 is substantially smooth and is shaped and sized to fit the patient's stomach when gastric band 410 is attached to it. The outer surface 438 of the balloon 414 is shaped and dimensioned for coupling with the inner surface 428 of the belt 412.

[0048] Referring to figures 11 to 16, the belt 412 and the balloon 414 can be coupled, respectively, through overmoulding or separate molding with subsequent adhesive bonding (similar numerals are used for the different modalities). Regardless of the manufacturing technique, the outer surface 438 of the balloon 414 is formed with a groove 439 molded and dimensioned to receive the belt 412. Referring to figures 15 and 16, in which the belt 412 is adhesively connected to the balloon 414, the groove 439 is formed with a space for glue 439a molded and sized to receive a small amount of adhesive, without adversely affecting the position of belt 412 within groove 439.

[0049] According to an alternative embodiment, and with reference to figure 17, it is considered that the balloon 414 'and the belt 412' can be coupled by the addition of a layer of uncured material 413 '(similar in composition to the components) between balloon 414 'and belt 412' and healing them together. In addition, a layer of reinforcing structure 415 '(mesh, non-similar material or higher durometer silicone material) is contained within the layer of uncured material 413'. This reinforcement structure 415 'is encapsulated within the device through assembly and curing and provides additional structure or different mechanical properties to the product.

[0050] In addition, and with reference to figures 18 to 21, still further construction of gastric band 410 is considered in accordance with the present invention. According to this embodiment, the belt 412 is attached along an inner surface 417 of the balloon 414, with the outer surface 428 of the balloon 414 forming the exposed outer surface 430 of the gastric band 410. As with the modalities

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14/30 described above, the inner surface 417 is formed with a groove 439 molded and dimensioned for receiving the belt 412. The secure positioning of the belt 412 within the groove 439 is achieved by providing a space for glue 439a along of the groove 439 and a retaining groove 439b along the length of the groove 439. The glue space 439a is substantially similar to that employed according to the embodiment described with reference to figures 16 and 17.

[0051] As for the retaining insert 439b, the groove 439 is constructed with opposite protrusions, directed inwards 439c molded and dimensioned to fit the belt 412 and temporarily retain the belt 412 within the groove 439, while the glue used to couple belt 412 and balloon 414 cure during the bonding operation. More particularly, the inwardly protruding protrusions 439c are shaped and sized to wrap around the belt 412 in order to support it within the groove 439c.

[0052] According to the preferred embodiment, the belt 412 is positioned inside the balloon 414 as follows. The belt 412 is threaded through one of the balloon openings 433, 435 at both ends 432, 434 of the balloon 414. The retaining insert 439b, specifically the protrusions 439c, in the groove 439 of the balloon 414, temporarily holds the components together while they are being glued through a long needle inserted between the balloon 414 and the belt 412. Alternatively, it is considered that the balloon can be overmoulded on the belt.

[0053] According to preferred modalities, and as briefly discussed above, the balloon and the belt can be attached together by means of adhesive bonding, co-molding, overmolding or mechanical connection (for example, coupling gloves), which holds the balloon and the belt in a way that results in the coupling of these distinct gastric band components. Where the belt and the balloon

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15/30 are overmolded, a plug 415 will be used to close the core outlet in the balloon to the overmold and the plug 450 will be integral with the gastric band structure (see figures 14 and 15). As those skilled in the art will certainly appreciate, co-molding is essentially the same procedure as overmoulding, but materials of different properties are loaded into the mold at the same time. As with overmoulding, co-molding requires a plug to close the outlet of the core in the balloon.

[0054] Regardless of how the product is molded or assembled together, the belt and balloon components can consist of the same or different materials (material durometer, fillers, such as BaSO ₄ , TiO ₂ , dyes, etc.) . In addition, characteristics within the same components (i.e., locking characteristics or end caps) may vary in composition. These characteristics can be adhered to the rest of the product with adhesive, mechanical fixation (that is, pressure fittings), welding, co-molding or over-molding. Although the belt is described as being attached to an external surface of the balloon, it is considered that the belt can be internal or external to the surface of the balloon or integrated into the balloon, without departing from the spirit of the present invention.

[0055] For assembly methods that allow the adhesion of different components (that is, adhesive bonding, mechanical connection, overmoulding), single belt and balloon components can be combined to provide variable configurations. For example, belts with different locking mechanisms can be interchanged with balloons of different lengths, in order to provide the possibility of multiple product combinations.

[0056] Balloon 414 is built to optimize contact with the stomach wall, when applied to it. With that in mind, and as will be discussed in more detail below, balloon 414 is constructed as a pre-curved, low pressure, high volume balloon. O

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16/30 balloon 414 is constructed to maintain a soft and flexible (low pressure) surface when applied to stomach tissue. Balloon 414 is also constructed to provide 360 degree coverage to prevent tightness or discontinuities in the shape of the stomach, and, as such, may employ the balloon construction described in US Patent Application, commonly assigned, Serial No. 11 / 182,070 , entitled GASTRIC BAND WITH MATING END PROFILES, filed on 07/15/2005, which is incorporated by reference. Balloon 414 is further constructed so that it reaches its fully inflated and enveloping configuration with minimal folds. In addition, balloon 414 is constructed to not show folds or folds (single geometric axis, not double geometric axis), when all the fluid is evacuated from it.

[0057] With the foregoing in mind, the balloon 414 employed in accordance with a preferred embodiment of the present application is constructed of an elastomeric material. Due to the design of this balloon, it does not inflate or expand in such a way as to cause high tension in the balloon, when filled, during gastric band adjustment. Previously, balloon 414 is adapted to receive a large volume of fluid under a relatively low pressure. In this way, balloon 414 receives fluid during application, but does not inflate or expand in a traditional manner, creating tension along the walls of balloon 414. In other words, when balloon 414 is filled to the recommended volume to obtain restriction the stomach, there is no expansion of the balloon material. In fact, balloon 414 fills up to a percentage of its total theoretical volume (that is, maximum filling volume). Since balloon 414 is not filled even close to its maximum filling volume, it remains at low pressure, allowing balloon 414 to conform to the stomach rather than the stomach to a rigid balloon.

[0058] In accordance with a preferred embodiment of the present invention, balloon 414 is designed with a maximum capacity of 870180006992, from 01/26/2018, p. 21/42

17/30 tre approximately 10 cc and approximately 18 cc and, preferably, 18 cc, although it will be completely filled for operation according to the present invention, in order to obtain the smallest stoma size, with approximately 9 cc to approximately 12 cc, and preferably 9 cc. By supplying a balloon 414, which is not in its capacity when properly filled, for operation, the balloon's smoothness and conformation is improved. Although specific volumes are described according to a preferred embodiment of the present invention, those skilled in the art will appreciate that filling volumes can be varied, without departing from the spirit of the present invention.

[0059] In addition, balloon 414 is manufactured in such a way that it exhibits a curved configuration when not tensioned. Although a variety of curvatures are possible within the spirit of the present invention, the curved configuration is designed to offer a radius of curvature from approximately 0.5 inches to approximately 1.5 inches. In addition, it is considered that the balloon may have a variable radius as it extends around its length. In general, the curvature of the balloon is designed to approximate the curvature required to place the first and second locking elements 422, 426 in approach or contact, when the balloon 414 is not skewed and is allowed to assume a relaxed configuration. By manufacturing the balloon 414 with an inherent curvature, folds created with the application of fluid are substantially reduced. With this in mind, the belt is similarly pre-curved to reduce folds and bring the first and second locking elements 422, 426 closer together.

[0060] As those skilled in the art will certainly appreciate, belt 412 is constructed to have a curvature that is approximately the same as that of balloon 414, so that undesirable tension between belt 412 and balloon 414 is reduced. In addition, and in consideration of the pre-curved nature of belt 412, belt 412 pronPetição 870180006992, of 26/01/2018, p. 22/42

18/30 exactly conforms to the outer surface of the stomach and belt 412.

[0061] Contact with the stomach tissue is further accentuated by the provision of the balloon 414 with a concave cross section along the internal surface 436 of the balloon. This cross-sectional configuration helps to facilitate evacuation and straightening.

[0062] By implementing the structural criteria outlined above, balloon 414 deflates without creases or bulges, forming on the internal surface 436 of balloon 414, a low pressure and pre-curved balloon 414 is obtained and balloon 414 changes its shape when it is filling (fip-lock bag filling). During the change in shape, the balloon 414 is constructed so that it has a relatively wider and smoother cross section before filling along a cross section, which is transversal to the longitudinal geometric axis of the balloon 414. When the balloon 414 is subsequently filled during application to a patient's stomach, the cross sectional shape of balloon 414 changes to that of a more rounded balloon, exhibiting a narrower cross section with a greater distance between the internal and external surfaces 436, 430 of the same. With this in mind, it is considered that the cross section of the balloon can be shaped into a rounded rectangular shape, in which the corners provide support, distribute the change in shape and reduce folds. By providing a balloon that is wide and flat before filling, the distance between the balloon's inner surface and the belt is reduced. This reduces the final profile of the gastric band and improves the ability of the gastric band to be readily distributed for use.

[0063] As those skilled in the art will certainly appreciate, a supply tube is used to connect the internal cavity of the gastric band balloon with a source of pressurized fluid. The use of the tube with a remote fluid source allows inflation and deflation of the balloon in a predetermined manner. The exact position of the

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19/30 tube is important because the surgeon does not want the tubing to be a visual obstruction during locking and / or other manipulation of the gastric band. In addition, once the placement of the gastric band is complete, the tube will not cause irritation to the surrounding tissue (for example, adherence, directly to the liver or spleen). Surgeons also do not want to pull the tube through the retrogastric tunnel, as they cannot easily see if the tissue is being damaged. The tube will also be able to act as a secure gripping place for manipulating the gastric band, the tube must not twist at the junction with the gastric band and prevent fluid flow and the location of the tube should facilitate the passage of the band through a small trocar.

[0064] With this in mind, and in accordance with various preferred embodiments of the present invention, different pipe settings are shown with reference to figures 22 to 31. As each of these various embodiments shows, the pipe is positioned at one end of the strip gastric. By positioning the tube at one end of the gastric band, it was found that by forcing the tube, the gastric band and, finally, the stomach, are reduced. This positioning also accentuates the ability of the tube and gastric band to flex for insertion and expand to its original shape through use.

[0065] Referring to figure 22, the tube 540 is oriented towards the exit of the gastric band 510 from its external surface. According to a preferred embodiment of this design, tube 540 is positioned so that it exits the outer surface 531 of gastric band 510 just below a median line that extends longitudinally 542 of gastric band 510. Tube 540 is positioned so that it is placed free of the locking mechanism 520 and obliquely at an angle to the longitudinal geometric axis (according to a preferred embodiment at an angle of approximately 34 °) of the gastric band 510 to allow easy insertion

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20/30 through a trocar.

[0066] Referring to figure 23, the tube 640 is molded at the second end 634 of the balloon 614. In particular, the tube 640 is molded at the end of the balloon 614 and is integrated in the form of a balloon. As with the previous modality, the tube 640 is oriented obliquely to the geometric axis longitudinally of the gastric band 610 and is positioned, similarly, below a median line, which extends longitudinally, from the gastric band 610. The deviation allows the ends 632, 634 of the balloon meet, without interference from the tube 640.

[0067] Another embodiment is shown with reference to figure 24, in which the tube 740 exits the balloon 714 on one side 744, that is, a very deep surface, of the balloon 714, while it is positioned inside the patient. The entry point of the tube 740 is substantially aligned with the second locking element 726 in relation to the longitudinal axis of the gastric band 710. As with the previous embodiments, the tube 740 is oriented obliquely with respect to the longitudinal axis of the gastric band 710 .

[0068] As shown in figures 25 and 26, the pipe connection 840 is integrated on one side of the locking elements. According to the described embodiment, it is integrated into the second locking element 826, although it is considered that it could be integrated with the first locking element 822, without departing from the spirit of the present invention. The tube 840 enters the second locking element 826 and extends through it in the body of the balloon 814. Once the tube 840 is inside the body of the balloon 814, it forms an angle with the center line (or median line 842) of the 814 flask for uniform filling of saline solution. Tube 840 is also oriented obliquely with respect to the longitudinally axis of the gastric band 810 and is similarly positioned below a median line that extends longitudinally 842 from the gastric band 810. The bypass allows the ends 832, 834

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21/30 of the balloon are without interference from the 840 tube.

[0069] Still other modalities are shown, respectively, with reference to figures 27 and 28. According to one embodiment, as shown in figure 27, the tube 940 is molded in the plug 946 used to cap the core portion of the balloon 914. According to another embodiment, as shown in figure 28, tube 1040 is molded as an integral portion of the second locking element 1026. The fluid passage therefore extends through tube 1040, in passages 1048 formed in the second locking element. lock 1026 and, finally, balloon 1014. More particularly, once tube 1040 enters a bridge of the second locking element 1026 (that is, where the second locking element 1026 defines the opening), it splits into one bifurcated tube 1052 which enters the balloon 1014 through both walls 1054 of the opening 1030 of the second locking element 1026.

[0070] Yet another embodiment is shown in figures 29 and 30, in which the tube 1140 is integrated on one side of the locking mechanism 1120, preferably the second locking element 1126. The tube 1140 then runs through a reinforcing iron 1156 from the rear of the second locking element 1126, to allow a low angle of entry into the balloon 1114.

[0071] Referring to figure 31, the inlet of the tube 1240 is integrated in the belt 1212 (and, more particularly, in the second locking element 1226) to allow the separate molding of the belt 1212 and the balloon 1214. When it is attached to the second locking element 1226, tube 1240 could be used to find the location of locking mechanism 1220, once the implant has been encapsulated in the fibrous tissue. As with the previous embodiments, the tube 1240 is oriented obliquely to the geometric axis longitudinally of the gastric band 1210 and is similarly positioned below a median line that extends longitudinally 1242 of the gastric band 1210. The deviation allows the extremities 870180006992 , of 26/01/2018, p. 26/42

22/30 units 1234 of the balloon meet, without interference from tube 1240. [0072] In addition, any of the piping configurations described with reference to figures 22 to 31 could incorporate some type of strain relief element to reduce fatigue as the tubing flexes back and forth across the body. This stress relief would be obtained by placing a thicker material length at the entry point of the tubing in the balloon (see, for example, 1156, in figure 29, similarly shown, but not evoked in figure 31). The length of the thicker material allows the tubing to take a wider curve as it is curved away from the junction between the tube and the balloon. In other words, this length of material that has been thickened increases the stiffness of the tubing in that region, to allow the tubing to flex without twisting and to move the flexion point further away from the vulnerable junction between the strip, the balloon and the tubing. The strain relief element will preferably be made of silicone, but other materials (plastics, metals, etc.) could also be used. Also in all of these modalities, the tubing could be connected to the belt or balloon by any of multiple manufacturing methods, such as overmoulding or assembly and gluing.

[0073] Although the present invention is described for use in conjunction with gastric bands, those skilled in the art will appreciate that the above invention has applicability, equally, to other types of implantable bands. For example, the bands are used to treat fecal incontinence. One of these ranges is described in U.S. Patent No. 6,461,292. The bands can also be used to treat bedwetting. One such band is described in U.S. Patent Application Publication No. 2003/0105385. The strips can also be used to treat heartburn and / or acid reflux. One of these ranges is described in U.S. Patent No. 6,470,892. The bands can also be used to treat impotence. One of these ranges is described in the Patent Application Publication

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23/30

No. 2003/0114729.

[0074] Referring to figures 1 and 2, the extender 100 includes an elongated body element having a first end 102 and a second end 104. The first end 102 includes an open recess 106, shaped and sized to receive the flap 24 of the first locking element 22 at the first end 14 of the gastric band 10. The first end 102 of the extender 100 is further provided with a fastening strip 108. The fastening strip 108 is shaped and sized to pass through the opening 38 formed in the flap 24 and final fixation within a coupling notch 110 formed on the outer surface of the first end 102 of the extender 100. In this way, the fastening strip 108, which extends from the extender 100 is linked through the flap 24, promptly coupling the first end 102 from the extender 100 to the first locking element 22 for selective fixing and separation.

[0075] The second end 104 of the extender 100 includes a gripping section 112 molded and sized to facilitate its grasp as the extender 100 is passed through the collar element 26 and the gastric band 10 is applied around the stomach. a patient. In addition, there is a suture loop 105 for compatibility with Goldfinger 150 instruments, as discussed above, and the grip section, or flat end, 112 of the extender 100 is compatible with the other band crossing devices. Between the first end 102 and the second end 104 of the extender 100, a laterally extending retaining element 114 is formed. The retaining element 114 is semicircular when viewed along a flat cross section. The retaining element 114 tapers to widen as it extends towards the first end 102 of the extender 100 in order to create a surface through which the collar element 26 can slide during locking for provisional attachment of the extender 100 to the element collar 26. The taper creates a locking surface 118,

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24/30 holding the collar element 26 between the enlarged first end 102 of the extender 100 and the retaining element 114, when the first end 102 of the extender 100 is temporarily locked in the collar element 26.

[0076] Although an extender with a recess and a retaining element according to the preferred embodiment is described above, the extender can take other forms, without departing from the spirit of the present invention. For example, and according to another preferred embodiment shown with reference to figure 9, the extension element 200 includes an elongated body element having an extreme front part 202 and second end 204. The first end 202 includes a pocket recess, closed , more particularly, a pocket 206, molded and dimensioned to receive, completely, the flap 24 of the first locking element 22 at the first end 14 of the gastric band 10. The first end 202 of the extension element 200 is further provided with a strip for clamp 208. The clamp strip 208 is shaped and sized to pass through the opening 38 formed in the flap 24 and final fixation within a coupling notch 210 formed on the outer surface of the first end 202 of the extension element 200. In this way, the the first end 202 of the extension element 200 can be readily and selectively secured and detached from the first locking element 22. [0077] The second ex tremor 204 of the extension element 200 includes a series of protrusions 212 shaped and sized to facilitate its grip as the extension element 200 is passed through the collar element 26 and the gastric band 10 is applied around the stomach of a patient. The second end 204 also includes a suture side 205 extending therefrom. Between the first end 202 and the second end 204 of the extension element 200, a laterally extending retaining element 214 is formed. The retaining element 214 includes first and second locking elements 216, 218. The retaining elements

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25/30 socket 216, 218 are tapered to widen as they extend towards the first end 202 of the extension element 200 in order to create a surface through which the collar element 26 can slide during locking for temporary fixing from the extension element 200 to the collar element 26, before the complete locking of the locking mechanism 20 of the gastric band 10 (after which the extension element 200 is separated from the gastric band 10). The taper creates opposite interlocking surfaces 220, 222, which support the collar element 26 between the first enlarged end 202 of the extension element 200 and the interlocking elements 216, 218, when the first end 202 of the extension element 200 is locked , temporarily, in the collar element 26. [0078] Regardless of the construction of the extensor used according to a gastric band, it is important that the extensor is readily accessed for removal, with little possibility of error. The two key issues in removing an extender revolve around a surgeon's ability to identify the extender, in particular, that part of the extender that requires manipulation for its removal and proceeds to remove the extension according to the removal mechanism employed. With that in mind, several modalities to ensure clear viewing and convenient cutting have been developed. Any of the modalities described below can incorporate a visual indicator, such as color (throughout the extender, the strap to secure or the only region to be cut) or a visible suture to indicate to surgeons that this is a separate component of the band gastric to be removed. In addition, these modalities also provide several means in which the extensor can be attached to the gastric band (strap to secure, suture, etc.).

[0079] More particularly, and with reference to figures 32, 33, 35 and 36, the extender 1300 adjacent its first end 1302 or to the strap for securing 1508, 1608 of the extender 1500, 1600 is provided with one or more projections or ramps 1330, 1530, 1630 in one location

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26/30 adjacent to the open coupling notch, or cavity 1310, in which the strip for securing 1308, 1508, 1608 of extender 1300, 1500, 1600 must be positioned. By providing a ledge or ramp 1330, 1530, 1630 in this position (at the first end of the extender or at the fastening strip), the fastening strip 1308, 1508, 1608 is held above the first end 1302 and the surgeon is able to readily view the location of the strip for securing 1308, 1508, 1608. The location of the ledge or ramp 1330, 1530, 1630 is in a position adjacent to the point where the strip for securing 1308, 1508, 1608 must be cut for removal the extender 1300, 1500, 1600 and therefore provides the surgeon with a visual indicator as to the cut location. According to the embodiment shown with reference to figure 35, two projections 1530a, 1530b completely wrap around the strip to secure 1508 and define an area where a surgeon will cut the strip to secure 1508.

[0080] In addition to improving the visualization of the strap to secure, in each mode the projections and ramps raise the strap to secure slightly above the gastric band, increasing the space between the strap to secure and the gastric band, in order to provide a improved passage for positioning scissors for cutting the strap to secure and final removal of the extender. The visualization of the cut location according to this modality is accentuated by providing a space or a notch 1332, 1432, 1532 along the strip to secure 1308, 1408, 1508 (see figures 32, 33, 34 and 35). In particular and with reference to figures 32, 33 and 43, the suture loop at the second end of the extender 1300, 2200 is continued throughout the body of the extender 1300, 2200, with suture 1334, 2234 extending through the strip to secure 1308 , 2208 and acting as a reinforcement element. However, a portion of the suture 1334, 2234 is exposed along the fastening strip 1308, 2208 at a predetermined location so that when the fastening strip 1308, 2208 is passed through the opening 38 of the gastric band flap 24 and wrapping around 870180006992, of 26/01/2018, p. 31/42

27/30 around the gastric band 10 to hold the two components together, the space 1332, 2232 is positioned in the desired location for cutting.

[0081] Similarly, and as seen in Figures 34 and 35, the strip for securing 1408, 1508 can have a localized region that is smaller than the rest of the strip for securing 1408, 1508, allowing for cutting in a single step. More particularly, the localized region is preferably a notch 1432, 1532 formed along the strip to secure 1408, 1508. Furthermore, as the space or notch 1432, 1532 is readily differentiated based on its physical appearance from the rest of the strip to attach 1408, 1508, a surgeon can easily identify the location that requires cutting. It is considered that the design of the notch or space could be used in conjunction with the projection described above with reference to figures 32, 33, 36, 42 and 43, although these drawings could certainly be used without the projection, where certain considerations of drawing impose themselves.

[0082] Other modalities are described with reference to figures 37, 39 and 40. These modalities employ a reinforcing element, for example, a suture 1734, 1934 to assist in the connection of the extensor 1700, 1900 to the tip of the gastric band. In one application (see figure 37), suture 1734 maintains the strip to hold 1708 to your body. As such, and prior to cutting the strip to secure 1708, as described above with reference to the various modalities, the fixing suture 1734 is cut to thereby release the secure strip 1708 for removal of the 1700 extender. Alternatively, the suture may be used to tie the strip and, as such, attach the strip to attach to the extender, without the aid of adhesive. Although the suture is described as a reinforcement element according to a preferred embodiment, other reinforcement structures, for example, mesh, can be used within the spirit of the present invention.

[0083] In another related embodiment shown in figures 39 and 40, the suture material of the 1905 suture loop is extended to run

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28/30 by the length of the extender 1900, so that the suture material 1934 extends from the first end 1902 of the extender 1900 (substantially, replacing the strap for fastening in the previous embodiments). This allows the 1900 extensor to wrap a 1934 suture through an opening 38 at the tip of the gastric band 10 and to fit a projection 1936 extending from the first end 1902 of the 1900 extensor. In addition to securing the gastric band in a safe and convenient manner, this modality provides additional benefits in that the 1934 suture now has a loop at the first end 1902 and at the second end 1904 of the 1900 extensor. This increases the strength of the 1900 extensor because the suture cannot be pulled from the extensor regardless of the failure of the extender.

[0084] Referring to figure 38, another modality is described. According to this modality, the tip 1812 of the gastric band 1810 is seated within the recess 1806 formed in the extensor 1800. However, the recess 1806 and the tip 1812 of the gastric band 1810 include a snap-in feature, providing a locking mechanism semimechanical between the gastric band 1810 and the extensor 1800. This modality will improve the ability of the extensor 1800 to take and guide the tip 1812 of the gastric band 1810 in agreement with twist or light touch. This semimechanical locking mechanism could be used in conjunction with the other strap fixing arrangements to secure as a means for providing redundant fixation of the extensor to the gastric band. It is still considered that this modality can have the suture 1811 around the tip 1812 of the gastric band 1810 and the recess 1806 of the extensor 1800 (as figure 37), to compress the region where the snapping point with snap 1812 inside the recess 1806 of the 1800 extender. When the surgeon cuts and removes the surrounding 1811 suture, he can then expand the flexible silicone extender 1800 through the snapped 1812 snap point in front of the flap to separate the

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29/30 1800 extensor gastric band 1810 in one piece.

[0085] Still and with reference to figure 41, a 2034 suture is used, similarly, in fixing the 2000 extensor to the gastric band. However, the projection 2036 to which the extender 2000 is attached is designed so that it can be pulled out. As such, when it is desired to remove the 2000 extender, it is only necessary to pull out the 2036 projection to release the 2000 extender and thus no cut is required.

[0086] Referring to figure 42, another modality is described. According to this embodiment, the strap 218 2108 of the extender 2100 is elongated to allow the glue position 2138 to be moved to a forward position in the extender 2100 of the open recess 2106. This allows the strap 2108 of the extender 2100 be cut in line 2140 to remove extender 2100. More particularly, open recess 2106 includes a forward position 2106a, positioned towards the middle of extender 2100, a back position 2106b positioned near the first end 2102 of extender 2100. The position of glue 2138 is at the front end 2106a. This is still a one-piece removal, only the length of the cut location has changed. This mode allows the strap to hold 2108 of arch for improved access with scissors or other instruments, when the front of the extender is flexed upwards, since the strap to hold is only glued on one end 2106a.

[0087] According to yet another modality, and with reference to figure 43, a flange or plug 2242 is positioned at a preset point along the length of the strip to hold 2208. This allows the positioning of the space 2232 on the strip to hold 2208 in relation to the position of extender 2200, where suture 2234 needs to be cut and to avoid having suturing contact with the hole and gastric band during pulling the band. The plug 2242 is positioned to fit the flap that surrounds the opening, in order to limit the extent to which the fastening strip 2208 can pass. The portion of the strip for

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30/30 holding 2208 adjacent to plug 2242 can be tapered and the section that is positioned inside the opening of the gastric band can be larger in cross section to provide a pressure fit with the hole in the gastric band. As with previous modalities, the strap will include a notched space or section for identification and cutting. In addition, the suture loop runs completely through the extender and can be used to tie it into a knot, which is molded into the extended section of the plug in order to optimize the resistance of the strip to secure the extender.

[0088] Although the preferred modalities have been shown and described, it will be understood that there is no intention to limit the invention through this exhibition, but rather, it is intended to cover all modifications and alternative constructions that are within the spirit and scope of the invention.

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1/2

Claims (9)

1. Gastric band (410), low pressure, high volume, comprising: a balloon (414) molded and sized to circumscribe the stomach at a predetermined location; a strap (412) that extends around the balloon (414); wherein the gastric band (410) is pre-curved to extend around the stomach; said balloon (414) including an inner wall (436) molded and sized to engage the patient's stomach when the gastric band (410) is attached to it, and an outer wall (438) shaped and sized to couple with the inner surface (428) of the belt (412); said belt (412) including an inner surface (428) molded and sized to attach to the outer wall (438) of the balloon (414), and an outer surface (430); and characterized by the fact that the outer wall (438) of the balloon (414) is formed with a groove (439) molded and dimensioned to receive a belt (412). 2. Gastric band (410), according to claim 1, characterized by the fact that the balloon (414) is pre-curved. 3. Gastric band (410), according to claim 2, characterized by the fact that the balloon (414) is a low pressure, high volume balloon (414). 4. Gastric band (410), according to claim 2, characterized by the fact that the belt (412) is pre-curved. 5. Gastric band (410), according to claim 1, characterized by the fact that the balloon (414) is a pre-curved, low-pressure, high-volume balloon (414), showing minimal folds or folds, when it extends in around the stomach. 6. Gastric band (410), according to claim 1, characterized by the fact that the belt (412) and the balloon (414) are Petition 870180006992, of 26/01/2018, p. 36/42 2/2 composed of different materials. 7. Gastric band (410), according to claim 1, characterized by the fact that the belt (412) and the balloon (414) are composed of the same material. 8. Gastric band (410), according to claim 1, characterized by the fact that the balloon (414) shows a 360 degree coverage around the stomach when the gastric band (410) is attached to it. 9. Gastric band (410), according to claim 1, characterized by the fact that the balloon (414) is devoid of folds or folds in the evacuation. Petition 870180006992, of 26/01/2018, p. 37/42